Kornimate/medical-research-clean huggingface dataset:
a 72-week randomized clinical trial comparing the safety and efficacy of three initial antiretroviral regimens -gpo-vir s (d4t/3tc/nvp) for 24 weeks followed by gpo-vir z (azt/3tc/nvp) vs gpo-vir z vs tdf/ftc/nvp

Conditions: HIV Infections

Summary: this protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of gpo-vir z or tdf/ftc/nvp for 18 months in arv-naïve patients to a 6-month lead in with gpo-vir s followed by 12 months of gpo-vir z. the primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.

gpo-vir z is a new combination antiretroviral (arv) medication that substitutes zidovudine (azt) for stavudine (d4t) from the original formulation of gpo-vir s. this new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4t. however, there is some risk that initiating therapy with an azt- containing regimen may cause unacceptable rates of anemia. many thai physicians have adopted a practice of using 6 months of the stavudine-containing gpo-vir s as a lead in before introducing azt-containing gpo-vir z in an effort to balance the risks and benefits of these two medications. there are no definitive data, however, that can attest to the benefit of such an approach.

Eligibility criteria:
inclusion criteria: 1. documented hiv-1 infection 2. age ≥ 18 years old. 3. subjects must be naïve to arv. individuals with past exposure to arv associated with pregnancy will be allowed to enroll as long as the exposure is at least 3 months prior to entry. 4. cd4 \< 350 cells/mm3 5. subject understands the study and is able to sign informed consent exclusion criteria: 1. evidence of symptomatic persistent symptoms of tingling or numbness of lower extremities and bilateral lower extremity neuropathy on exam at entry. abnormal exam includes 1) diminished (compared with the knee) or absent ankle reflexes or 2) diminution of either vibration sensation in the legs (defined as perception of vibration for \< 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) or 3) diminution of pin or temperature sensation in lower extremities or 4) contact allodynia in the feet. 2. laboratory values 1) absolute neutrophil count (anc) \ 5 x uln 4) creatinine \> 2 x uln or \< creatinine clearance \< 30 cc per min by cockroft-gault formula 3. active aids-defining opportunistic infection (oi) within 30 days prior to entry. subjects must be off all acute treatments for oi for at least 14 days prior to entry. subjects on maintenance or prophylactic therapy for aids-related ois will be eligible. 4. any immunomodulator, hiv vaccine or investigational therapy within 30 days of study entry 5. pregnancy or breast-feeding; intent to become pregnant during the course of the study. 6. presence of any active malignancy.

Keywords: hiv/aids patients
a phase 3 safety and efficacy study of fovista® (e10030) intravitreous administration in combination with either avastin® or eylea® compared to avastin® or eylea® monotherapy

Conditions: Age-Related Macular Degeneration

Summary: the objectives of this study are to evaluate the safety and efficacy of intravitreal administration of fovista® administered in combination with either avastin® or eylea® compared to avastin® or eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (amd).

subjects will be randomized in a 1:1 ratio to the following two arms per study design: * fovista® 1.5 mg/eye + avastin® 1.25 mg/eye or eylea® 2 mg/eye * fovista® sham + avastin® 1.25 mg/eye or eylea® 2 mg/eye subjects will be treated for up to 24 months with active fovista® or sham, in combination with either avastin® or eylea® with the primary endpoint at 12 months. approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the sap

Eligibility criteria:
inclusion criteria: * subjects of either gender aged ≥ 50 years * active subfoveal choroidal neovascularization (cnv) secondary to amd * presence of sub-retinal hyper-reflective material (sd-oct) exclusion criteria: * any prior treatment for amd in the study eye prior to the day 1 visit, except oral supplements of vitamins and minerals * any prior intravitreal treatment in the study eye prior to the day 1 visit, regardless of indication (including intravitreal corticosteroids) * any intraocular surgery or thermal laser within three (3) months of trial entry. any prior thermal laser in the macular region, regardless of indication * subjects with subfoveal scar or subfoveal atrophy are excluded * diabetes mellitus

Keywords: wet amd choroidal neovascularization fovista® e10030 avastin® eylea®
cold dissection versus electrocautery dissection in endoscopic nipple-sparing mastectomy and immediate implant-based reconstruction: a randomized controlled trial

Conditions: Breast Neoplasms

Summary: the purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. the purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

breast cancer is the most common cancer among women in the world. although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. despite oncologic and surgical safety of nipple-sparing mastectomy(nsm) with immediate breast reconstruction(ibr) were amply demonstrated, a number of acute and late complications can occur. surgical technique may play a role in the postoperative outcomes of mastectomy skin flap.previous studies suggest that cold dissection with scissors or scalpel, may lead to decreasing blood loss and rates of skin necrosis, compared to electrocautery. a retrospective study by troy ng demonstrated that the use of cold dissection is likely to decrease the rate of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%, p=0.02). the purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.

Eligibility criteria:
inclusion criteria: * tumor smaller than 5 cm * no evidence of nac, skin or chest wall invasion. * the general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to e-nsm as well. exclusion criteria: * patients with apparent nac involvement, chest wall or skin invasion, inflammatory breast cancer, locally advanced breast cancer or severe comorbid conditions or poor performance status assessed by the primary physicians, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.

Keywords: endoscopy mastectomy breast implants necrosis dissection
metabolic abnormalities in hiv infected and uninfected young women

Conditions: HIV Infections; Hypercholesterolemia; Glucose Intolerance

Summary: though anti-hiv drugs can dramatically improve the health of people with hiv, some people taking these drugs develop serious long term effects in their metabolism. these effects include problems with bones, increased levels of blood sugar and lipids, and changes in body fat distribution. the purpose of this study is to see how many young women are experiencing these problems and how severe the problems are. this kind of study is the first step in determining how best to treat these problems.

patients on highly active antiretroviral therapy (haart) regimens develop potentially deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and osteoporosis, and hyperlactatemia. changes in body fat distribution and bone metabolism are also documented. there is considerable evidence that protease inhibitors (pi) can induce insulin resistance and increase triglyceride and cholesterol levels. it is now also clear that both metabolic changes and fat distribution abnormalities occur in pi-naive patients treated with nucleoside analogue reverse transcriptase inhibitors (nrtis). in addition to class specific effects, there is emerging evidence that there are differences within each class of drug in the nature and magnitude of metabolic effects. this study will examine the metabolic effects of haart in young women. adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata: stratum 1 - hiv uninfected; stratum 2 - hiv infected but never had haart; stratum 3 - hiv infected on nnrti regimen for 3 or more months and less than 2 weeks of pi therapy; stratum 4 - hiv infected on pi regimen for 3 or more months and less than 2 weeks of nnrti therapy; and stratum 5 - hiv infected on nrti-only regimen for 3 or more months and less than 2 weeks of pi or nnrti therapy. participants in the study will have one study visit conducted over 1 or 2 days. the study visit will include survey questionnaires, dexa scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism.

Eligibility criteria:
inclusion criteria * negative serum or urine pregnancy test if not sterilized * tanner stage 4 or 5 * accessible medical and medication history * willing to fast and complete clinical and laboratory evaluations * willingness and ability to give consent or assent with parental permission exclusion criteria * refusal to fast for 8 hours prior to specimen collection * unable to obtain history * pregnancy in last 12 months or currently pregnant * history of anorexia or bulimia * type i diabetes mellitus * type ii diabetes mellitus and cannot omit medication for the 48 hour period prior to laboratory specimen collection

Keywords: treatment experienced treatment naive
modified transplantation regimen and agvhd prophylaxis for severe aplastic anemia in the setting of allogeneic hematopoietic stem cell transplantation

Conditions: Aplastic Anaemia; Transplantation Conditioning

Summary: we retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and agvhd prophylaxis in severe aplastic anemia in two clinical center.

aplastic anemia (aa) is a group of myelo-hemopoietic failure syndromes caused by a variety of etiologies. if not intervened, the average expected survival time is less than half a year.allogeneic hematopoietic stem cell transplantation (allo-hsct) is one of the possible cures for this disease. the success rate of treatment for this disease can be further improved under the previous regimen system. the survival rate reported in the literature is 60%-90%. from jun. 2020 to jun 2023, 52 patients in two transplantation center received this modified transplantation system, we designed this clinical trial to retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and agvhd prophylaxis in severe aplastic anemia in these two clinical center.

Eligibility criteria:
inclusion criteria:1.patients who were diagnosed with severe aplastic anemia by nccn guidelines, and has received hsct with this transplantation preconditioning and agvhd prophylaxis regimen; 2.age 3-65 years old; 3.weight 10kg-100kg; 4.eastern cooperative oncology group (ecog) score ≤3; 5.no major organ injury (ecg ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; ast and alt \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value); 6.no severe infection; 7.subjects voluntarily participated in this clinical trial and signed the informed consent. - exclusion criteria:1.patients with other hematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation; 2.patients with an expected survival of less than 1 month; 3.patients with previous autologous or allogeneic hematopoietic stem cell transplantation; 4.pregnant patients; 5.patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events; 6.other conditions that the investigator determines to be inappropriate for enrollment. -

Keywords: modified transplantation conditioning aplastic anemia agvhd prophylaxis
the treatment of cartilaginous lesions and concomitant anterior cruciate ligament reconstruction

Conditions: Cruciate Ligament Rupture; Cartilage Injury

Summary: the aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.

the anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. the mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament. the treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions. in order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.

Eligibility criteria:
inclusion criteria: 1. male or female patients, 18 \< age \< 55; 2. patients with complete acl injury candidates for surgical reconstruction of the same; 3. cartilaginous lesion of the femur-tibial compartment of grade iii-iv icrs ≤3 cm2 confirmed intra-operatively; 4. patients without evidence of osteoarthritis 5. patients' ability and consent to participate in clinical and radiological follow-up; 6. signature of informed consent. exclusion criteria: 1. patients incapable of understanding and of wanting; 2. state of immunodepression; 3. patients with malignant neoplasms; 4. patients suffering from rheumatic diseases; 5. patients suffering from non-compensated diabetes; 6. patients suffering from uncompensated thyroid metabolic disorders; 7. patients abusing alcoholic beverages, drugs or drugs; 8. patients with axial deviations\> 5 °; 9. body mass index\> 35; 10. patients treated with surgery at the same knee in the previous 12 months. 11. cartilaginous lesions grade i-ii according to the icrs score. 12. cartilage lesions with a diameter greater than 3 cm². 13. non-suturable meniscal lesions requiring meniscectomy\> 50% and patients with previous meniscectomies\> 50% in the same compartment. 14. need for further associated surgical procedures in addition to the reconstruction of acl and possibly the nanofractures.
clinical validation of colonaiq (a blood-based assay targeting ctdna methylation) for colorectal cancer detection

Conditions: Colorectal Cancer

Summary: the dna methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (colonaiq), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.

the accuracy of colonaiq test in clinical testing will be evaluated in the multicenter, prospective study. patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. in this study, all cfdna will be tested by fluorescence quantitative pcr, and some samples will be tested by ngs to verify the effectiveness of colonaiq test. clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, gender is not limited; 2. meet one of the following conditions: 1) suspected colorectal cancer (crc); 2) diagnosed with crc according to clinical diagnostic criteria; 3) do not have crc and have interfering diseases: 1. confirmed non-crc digestive tract cases: colorectal polyps, adenomas, and other benign diseases of the digestive system; 2. confirmed cases of other cancers other than crc: gastric, esophageal, breast, and lung cancer; 3. diseases where the same gene methylation may be present (non-rheumatoid arthritis, etc.); 3. the subject or his/her guardian is able to understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign the informed consent. exclusion criteria: 1. people who cannot tolerate relevant tests for clinical diagnosis; 2. pregnant women; 3. patients who have previously received colorectal cancer surgery, tumor drug therapy, neoadjuvant therapy, or radiotherapy; 4. other conditions deemed unsuitable for inclusion by the investigator.
a 56-week extension to a clinical study to assess the efficacy and safety of vildagliptin compared to placebo in drug naive patients with type 2 diabetes and mild hyperglycemia

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. the purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Eligibility criteria:
inclusion criteria: * completion of study claf237a2307 within 4 weeks of entering into the extension * written informed consent * ability to comply with all study requirements * blood glucose criteria must be met exclusion criteria: * premature discontinuation from study claf237a2307

Keywords: type 2 diabetes vildagliptin
comparison study of rituximab plus sargramostim to rituximab alone for relapsed follicular b-cell lymphoma, a form of non-hodgkin's lymphoma

Conditions: Lymphoma, Follicular

Summary: the purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.

on 29 may 2009, bayer began transitioning the sponsorship of this trial to genzyme. as of 29 august 2009, genzyme assumed responsibility for the close out of the study. note: this study was originally posted by sponsor berlex, inc. berlex, inc. was renamed to bayer healthcare, inc. the study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.

Eligibility criteria:
inclusion criteria (abbreviated list): * relapsed follicular b-cell lymphoma * one or more previous therapies for non-hodgkin's * at least one measurable tumor by ct scan or mri * additional criteria to be determined at screening visit exclusion criteria (abbreviated list): * rituximab refractory (less than 6 months from last treatment with rituximab to relapse) * currently receiving treatment for another cancer * infection currently being treated * active hepatitis b * history of hiv infection * pregnant * additional criteria to be determined at screening visit

Keywords: sargramostim leukine nhl
risk factors related to metabolic syndrome in school-aged children who were born preterm

Conditions: Metabolic Syndrome

Summary: this is a follow-up cohort study of 8 years old children born preterm at seoul national university children's hospital in korea from 2008-2009. the children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome. the purpose of this study is to compare growth and risk factors of metabolic syndrome among children born preterm and children born healthy term at school age


Eligibility criteria:
inclusion criteria: * very low birth weight infants and/or born less than 32 weeks of gestation age * healthy term infants for control group * parents and children accept of participation exclusion criteria: * major congenital anomalies * neuromuscular disease * chromosomal anomalies * patients receiving growth hormone therapy * primary hypothyroidism
efficacy study of hydroxychloroquine to treat high-risk coronary artery disease.

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate whether treated with hydroxychloroquine could improve therapeutic effect for patients with high-risk coronary artery disease.

this double blind, placebo, randomized controlled trial is going to assess if hydroxychloroquine could improve the high sensitivity c-reaction protein, blood lipid, blood glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of inflammatory cytokines and the m1/m2 phenotype polarization of macrophages in patients with high-risk coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients have been diagnosed coronary artery disease by coronary angiography or ct angiography. * coronary artery disease with hypertension or diabetes or hyperlipidaemia(ldl\>1.8mmol/l) * high sensitivity c-reactive protein \>1mg/l. * on guideline-based secondary prevention of coronary heart disease medications≥1 months. * no use of steroids, antibiotics, immunosuppressors a week before treatment. exclusion criteria: * retinal disease. * chronic hepatopathy(alt\>120u/l). * renal dysfunction (egfr\<60). * moderately severe anemia, thrombocytopenia and leukocytopenia. * other contraindications for hydroxychloroquine. * active hemorrhage. * cancer or life expectancy\< a year. * new york heart association (nyha) functional class≥class iii, percutaneous coronary intervention or coronary artery bypass grafting in plan. * pregnancy and lactation.

Keywords: coronary artery disease hydroxychloroquine
biomarkers of atrial fibrillation complicated with stroke based on proteomics and metabolomics

Conditions: Atrial Fibrillation; Stroke

Summary: thrombus shedding in patients with atrial fibrillation (af) can lead to cerebral artery embolism. stroke caused by af is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. this study aims to explore the biomarkers of stroke in patients with af by integrating proteomics and metabolomics data, and establish the network relationship of stroke in patients with af, so as to reveal the molecular mechanism of stroke in patients with af.


Eligibility criteria:
inclusion criteria: 1. age 18 years or above 2. admission with atrial fibrillation or clinic visit for atrial fibrillation 3. receive routine anticoagulant therapy; 4. signing the consent form exclusion criteria: 1. pregnant women; 2. lactating women; 3. severe mitral stenosis; 4. severe impairment of liver function; 5. severe renal insufficiency; 6. thyroid dysfunction requiring treatment.

Keywords: atrial fibrillation stroke metabolomics proteomics biomarkers